Recruiting

Self-Help Plus

Sponsor:

The New School

Code:

NCT07188467

Conditions

Stress, Psychological

Depression and/or Anxiety in the Mild-to-moderate Range

Loneliness

Adjustment, Psychological

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Digitized SH+

Study Details

Brief summary:

The goal of this clinical trial is to learn if an adapted version of Self-Help Plus (SH+), a stress management program developed by the World Health Organization, can reduce stress and improve well-being in international students at a U.S. university. The main questions it aims to answer are:

Does SH+ reduce perceived stress, anxiety, and depressive symptoms in international students? Does SH+ improve feelings of social support, self-efficacy, and adjustment in a new cultural environment?

Participants will:

Attend a two-day in-person workshop that includes animated videos, interactive activities, and group discussions.

Complete three surveys (before the workshop, right after, and six weeks later) about stress, mood, and well-being.

Optionally, take part in a short interview to share feedback about their experience.

Conditions

Stress, Psychological

Depression and/or Anxiety in the Mild-to-moderate Range

Loneliness

Adjustment, Psychological

Study ID

NCT07188467

Start date

Oct 7, 2025

Status verified date

Oct, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Enrolled as an international student at The New School
  • Age 18 years or older
  • Willing to provide informed consent and complete study assessments
  • Score of ≥3 on the PHQ-4, indicating at least mild distress
  • Sufficient English proficiency to comprehend intervention materials

Exclusion Criteria:

  • Severe psychiatric conditions requiring immediate intervention (e.g., active psychosis, severe mood disorders)
  • Visual, hearing, or neurocognitive impairments that prevent engagement with the intervention
  • Having an advanced degree in psychology or mental health-related fields (to prevent prior knowledge bias)
  • Score of 2 or higher on PHQ-4 Item 3 or Item 4 (frequent thoughts of self-harm or severe distress)

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Self-Help Plus (SH+) Workshop

Participants will attend a two-day in-person workshop featuring digitized SH+ materials. The workshop includes animated videos, guided stress management exercises, and group discussions.

Interventions

Digitized SH+

Digitized SH+ is a group-based, stress management program (adapted from the original Self-Help Plus intervention developed by the World Health Organization), that utilizes animated videos and group discussions to teach participants skills such as Grounding, Unhooking (from difficult thoughts), Being Kind (to self and others), Identifying Values, and Making Room for Difficult Thoughts and Feelings.

Primary outcome measure

  • Perceived Stress Scale (PSS-10) [ Time Frame: Change from baseline to 6-week follow-up ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline to 6-week follow-up ]
  • General Anxiety Disorder (GAD-7) [ Time Frame: Change from baseline to 6-week follow-up ]

Central Contacts and Locations

Central contacts

Locations

The New School

Recruiting

Brooklyn, New York, United States, 10011

Contacts

Principal Investigator:

Adam D. Brown, PhD

More Information

Sponsor

The New School

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New School on 2025-10-09.